CETA tracker: Final Regulations released

Final CETA regulations impacting pharmaceuticals published but not yet in force

As we reported, in July the Canadian government released draft versions of the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30. On September 7, the government released the final versions of the regulations.

PM(NOC) Regulations

Despite receiving “a number of submissions” from stakeholders reiterating concerns raised in earlier consultations and raising new concerns, the government decided against making any further changes to these regulations.

Certificates of Supplementary Protection Regulations

The government has removed the requirement that a patent be at least two years from expiration on the date of the CSP application to be eligible for a CSP.

The requirement that the Canadian NDS for the drug in question must be filed within 18 months of any first international drug submission filing for the same drug in the European Union, United States, Australia, Switzerland or Japan (“timely submission requirement”) has been extended from 18 to 24 months during the first year of the regime. This change was made to allow for a sufficient transition period.

Implementation

The government has also confirmed that Bill C-30 and the new regulations will be implemented on September 21, 2017.

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